A randomised placebo-controlled trial of the effect of hormone replacement therapy on dementia and cognitive function in post-menopausal wome

Completed

Conditions: Obstetrics and gynaecology
Urological and Genital Diseases
Post-menopause

Registration Number: ISRCTN55999335

Lead Sponsor: Medical Research Council (MRC) (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 14240

Inclusion Criteria

Age 50-69, female, post-menopausal, no contraindication to HRT.
For both components, in addition to the WISDOM trial inclusion criteria, subjects will only be recruited if they can be randomised to receive placebo, ie excluding the 21% of WISDOM recruits with a total hysterectomy who are already taking HRT.
For the dementia component sub-study only those who will reach the age of 65 years before the end of the projected follow-up period (2009) will be included.

Exclusion Criteria

Not provided at time of registration

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dementia component: The principal outcome will be onset of dementia according to ICD-10 criteria. <br><br>Cognitive component: Change of cognitive test performance on the Wechsler Logical Memory Recall. <br>The trial will have 90% power, at the 5% significance level, to detect an effect size, associated with randomisation to HRT, of 0.5 or greater enabling us to detect a difference of two story components recalled out of a total of 25 for Wechsler Logical Memory story recall.<br><br>Added 19/08/09: Follow up duration for primary endpoints Dementia component - 2009 (10 years) Cognitive component - Five years

Secondary Outcome Measures

Name	Time	Method
Dementia component: The secondary outcome will be onset of the dementia sub-type diagnosis of Alzheimer's disease (AD) diagnosed according to NINCDS-ADRDA criteria (possible and probable).